Celecoxib in Preventing Lung Cancer in Former Heavy Smokers

Lung Cancer Clinical Trial

Official title:

Lung Cancer Chemoprevention With Celecoxib In Ex-Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00055978
• Other study ID #: CDR0000271912
• Secondary ID: U01CA096134P30CA
• Status: Completed
• Phase: Phase 2
• First received: March 6, 2003
• Last updated: June 16, 2011
• Start date: October 2002
• Est. completion date: May 2009

Study information

• Verified date: June 2011
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Chemoprevention therapy uses certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing the development or recurrence of lung cancer in former heavy smokers.

PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing the development or recurrence of lung cancer in former heavy smokers who are at risk of developing cancer.

Description:

OBJECTIVES:

• Determine the feasibility of chemoprevention of lung cancer with celecoxib in former heavy smokers at risk for developing primary or second primary lung cancer.

• Determine the safety and side effects of this drug in these patients.

• Determine the quality of life of patients treated with this drug.

• Determine the role of COX-2-specific inhibitors (e.g., celecoxib) on antitumor immunity within the lung microenvironment of these patients.

• Determine the effects of COX-2 inhibition on angiogenesis in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to presence of preinvasive lesions (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral placebo twice daily for 6 months.

• Arm II: Patients receive oral celecoxib twice daily for 6 months. Treatment in both arms continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed every 6 months during treatment and then annually for up to 4 years.

Patients are followed annually for up to 4 years.

PROJECTED ACCRUAL: A total of 180 patients (90 per treatment arm) will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: May 2009
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Heavy former smokers without prior history of NSCLC

• Age > 45

• Smoked for minimum of 30 pack years

• Former smokers with prior curative resection of surgical stage I NSCLC will be recruited and must be:

• Age > 18

• Smoked > 10 pack years

• Must have had pathological staging and the extent of disease documented. At least one nodal station each must have been biopsied and all biopsies must have been negative

• At least 6 months post curative resection of Stage I prior NSCLC, without evidence for recurrence or second primary lung cancer

• Normal blood chemistry and cell counts

• Negative pregnancy test

Exclusion Criteria:

• Framingham 10-year-risk for coronary artery disease score > 10%

• History of cardiovascular disease

• Evidence of diffuse coronary calcification on screening CT

• Concurrent use of NSAIDs. The use of cardiac (baby) Aspirin is permitted

• Hypersensitivity to celecoxib, sulfonamides, aspirin or other NSAIDs

• Liver dysfunction [abnormally elevated liver function tests [transaminases (ALT, AST) > ULN, alkaline phosphatase (ALKP) > 1.5 ULN]] or history of cirrhosis

• No peptic ulcer disease (PUD) diagnosis nor active symptoms in the last 2 years or, if PUD was diagnosed < 2 years, there must be no active symptoms, and endoscopic confirmation of healing

• Renal dysfunction [abnormally elevated blood urea nitrogen (BUN) > 1.5 ULN and creatinine > ULN]

• End state respiratory disease

• Unstable angina or a history of significant coronary artery disease

• Other malignancies excluding non-melanoma type skin cancer and in situ cervical cancer. Persons with stage I/II head and neck cancer must be disease free for at least 12 months

• Pregnancy

• Lactation

• Unwillingness to practice contraception

• On systemic corticoid steroid therapy

• Coagulopathy

• Use of Coumadin

• Concurrent use of medication know to alter or be affected by alteration of hepatic p450 2C9 enzymes.

• Patients with concurrent medical conditions that may interfere with completion of tests, therapy, or the follow up schedule

• Patients who had received photosensitizing agents such as hematoporphyrin derivative or chemopreventive drugs such as retinoids within 3 months prior to the bronchoscopic procedure, radiotherapy to the chest, or cytotoxic chemotherapy agents

• Subject found to have CIS during screening bronchoscopy will be treated with local therapy prior to randomization

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• celecoxib
Given orally. 400mg twice daily for 6 months.

Other:
• placebo
Given orally

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modulation of the ki-67 labeling index		5 years
Primary	Phenotypic modulation of the bronchial histology		5 years
Secondary	Evidence of molecular/genetic aberrations		5 years
Secondary	Changes indicative of response to treatment in the targeted signaling pathway		5 years
Secondary	Parameters that reflect the overall balance of the epigenetic phenomenon thought to facilitate or promote tumorigenesis		5 years